Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:48 AM
Ignite Modification Date:
2025-12-26 @ 11:48 AM
NCT ID:
NCT06340516
Eligibility Criteria:
Inclusion Criteria:
1. Histological confirmed HER2 positive primary BC planned for adjuvant/neoadjuvant treatment with chemotherapy plus HER2 blocking agents.
2. Patients ≥18 years
3. ECOG/WHO 0-1
4. Adequate organ function for the planned treatment according to local guidelines.
5. No distant metastasis (CT/MRI only if clinically indicated).
6. Negative pregnancy test within 14 days prior to start of treatment.
7. If of childbearing potential, willing to use an effective form of contraception.
8. No other malignancy during the last 5 years except for radically treated basal or squamous cell carcinoma of the skin or CIS of the cervix.
9. Signed informed consent and willingness to follow the trial procedures.
Exclusion Criteria:
1. Patients with previous heart disease recommended special follow-up during treatment with high risk of termination of treatment.
2. Evidence of any other medical conditions (such as psychiatric illness, infectious diseases, neurological conditions, physical examination or laboratory findings) that may interfere with the planned treatment or affect patient compliance.
3. Pregnancy and breast feeding.
4. Concurrent malignancy requiring therapy (excluding non-invasive carcinoma or carcinoma in situ).
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Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06340516
Study Brief:
Protocol Section:
NCT06340516